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Observational / Obesity / Gut Microbiota · Observational Study
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry entry for a planned observational study investigating associations between gut microbiota composition, immune markers, and susceptibility to chronic infections in patients with obesity and type 2 diabetes. No results have been posted in this registry record, and the study is currently recruiting. The work is hypothesis-generating, designed to identify microbial phyla associated with infection risk rather to test an intervention or establish causal relationships.
Observational. Obesity, Type2diabetes, Gut Microbiota, Chronic Disease; age from 18 Years; to 65 Years; accepts healthy volunteers. Intervention: case (patients having chronic infections); control (patients without chronic infections). Compared with: Case–control comparison. n = 80. 1 site: Italy.
This is a registry entry for a planned observational study investigating associations between gut microbiota composition, immune markers, and susceptibility to chronic infections in patients with obesity and type 2 diabetes. No results have been posted in this registry record, and the study is currently recruiting. The work is hypothesis-generating, designed to identify microbial phyla associated with infection risk rather to test an intervention or establish causal relationships.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This registry record alone does not support clinical decision-making; it describes a study in recruitment. Results, once posted, may generate hypotheses about microbial drivers of infection risk in metabolic disease but are unlikely to directly guide practice without validation in intervention trials.
This is a clinical trial registry record describing a planned observational study with no results posted; it represents early-phase hypothesis-generating work examining associations between microbiota, immunity, and infection susceptibility in obesity.
As stated by the source record.
Quoted from the source exactly as published.
This registry record alone does not support clinical decision-making; it describes a study in recruitment. Results, once posted, may generate hypotheses about microbial drivers of infection risk in metabolic disease but are unlikely to directly guide practice without validation in intervention trials.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05975541). This is a study registration, not published results. Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 80 participants (ESTIMATED). Conditions: Obesity, Type2diabetes, Gut Microbiota, Chronic Disease. Interventions: OTHER: Observational. Primary outcome measures: Omic signature differences between group of case and group of control , Changes in microbiota composition between time 0 months (start point of the study) and 12 months (end point of the study); Immune system differences between group of case and group of control , Changes in the level and type of pro-inflammatory cytokines between basal time, 0 months , 6 and 12 months (end of the study) in both case and control group; Patient card for the evaluation of the pharmacological therapy , changes between time 0 months (basal time) and 12 months (end of the study); Identification of the oral microbiota , changes in oral microbiota between the two different groups at time 0 months, 6 months and 12 months; Number of white blood cells , changes in WBC biochemical levels between time 0 months, 6 months and 12 months in both case and control groups; Blood cells count , changes in blood cells count between time 0 months, 6 months and 12 months in both case and control group; Lipid profile identification , changes in lipid profile between time 0 months, 6 months and 12 months in both case and control group; Uric acid concentration , changes in uric acid levels between time 0 months, 6 months and 12 months in both case and control group; Evaluation of urine parameters , changes in microalbuminuria and creatinuria levels between time 0 months, 6 months and 12 months in both case and control group; Concentration of vitamin D , changes in vitamin D levels between time 0 months, 6 months and 12 months in both case and control group; Detection of immunoglobulins , changes in immunoglobulins profile between time 0 months, 6 months and 12 months in both case and control group; QPE index evaluation , Changes in QPE index level between time 0 months, 6 months and 12 months in both case and control group; Concentration of electrolyte levels , Changes in the electrolyte levels between time 0 months, 6 months and 12 months in both case and control group; Detection of haptoglobins level , Changes in haptoglobins levels between time 0 months, 6 months and 12 months in both case and control group; Fecal calprotectin levels identification , Changes in fecal calprotectin levels between time 0 months, 6 months and 12 months in both case and control group. Brief summary: The role of intestinal microbiota is becoming ever more important in the context of obesity, type II diabetes (T2D), and infectious disorders as represented by the emerging discipline "therapeutic microbiology". The gut microbiota is strictly interconnected with obesity and T2D playing also an important role in immune system regulation. Obesity and diabetes can lead to chronic inflammation, which results in the secretion of pro-inflammatory cytokines like IL-6, IL-1, and TNF-alpha, causing immune system alteration which predisposes patients with obesity and T2D to chronic infections. Therefore, the principal aim of the study is to investigate changes in gut microbiota composition between patients with chronic infections or not, so as to attribute to specific phyla the formation of the infections in these patients.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.